The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9-valent human papillomavirus (9vHPV) vaccine. No hypothesis will be tested since this study is an estimation-only study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
314
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Sotobo Children's Clinic ( Site 6616)
Isumi, Chiba, Japan
Ohigesenseino Kodomo Clinic ( Site 6607)
Sapporo, Hokkaido, Japan
Motomachi Pediatric Clinic ( Site 6606)
Sapporo, Hokkaido, Japan
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.
Time frame: 1 month after final dose (Month 7)
Number of Participants With at Least 1 Injection-site Adverse Event (AE)
The number of participants with injection-site AEs (erythema/redness, pain and swelling) is reported. An AE any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to 5 days after each vaccination (up to ~6 months)
Number of Participants With at Least 1 Systemic Adverse Event
The number of participants with a systemic AE is reported. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to 15 days after each vaccination (up to ~6.5 months)
Number of Participants With at Least 1 Serious Adverse Event (SAE)
The number of participants with an SAE is reported. An SAE is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention.
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Medical Corporation Bunmeikai Okuda E.N.T ( Site 6611)
Sakai, Osaka, Japan
Fukui General Hospital ( Site 6614)
Fukui, Japan
Nomura Clinic Namba ( Site 6608)
Osaka, Japan
Medical Corporation Kanyukai Kikumori Otolaryngology Clinic ( Site 6612)
Osaka, Japan
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6603)
Tokyo, Japan
Okawa Children & Family Clinic ( Site 6610)
Tokyo, Japan
Shinjuku Higashiguchi Clinic ( Site 6602)
Tokyo, Japan
...and 2 more locations
Time frame: Up to ~Month 30
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
The GMT for each HPV serotype is presented. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA).
Time frame: 1 month after final dose (Month 7)